N1
FDA 510(k) clearance K232012 · decided 2023-11-28
Clearance details
- K-number
- K232012
- Device name
- N1
- Applicant
- Osstem Implant Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-06
- Decision date
- 2023-11-28
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- EHD
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Siheung-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.